(1) Field of the Invention
The present invention relates to a method and test kit for the diagnosis of an inherited substance abuse dependency in humans as a basis for subsequent treatment. In particular, the present invention relates to a method and test kit which detects low levels of lymphocyte T-cell suppressor cells (CD8) as evidence of the inherited substance abuse trait.
(2) Prior Art
The use and abuse of alcohol and other mind altering drugs which can be coupled with chemical dependency is a very serious problem. Alcoholism and mixed chemical dependency of alcohol with other drugs is a major concern of the health care system. It is a major concern of the gross national indebtedness of the U.S.A. with estimates ranging from $116 billion annual loss in manpower to $125 billion of the national health care cost. This is a total cost of over $200 billion being lost due to a disease called "alcoholism". The range of the economic consequences of alcoholism is felt on the industrial line, through airplane accidents, motor vehicle accidents, and from major oil spills to legislative leaders who are intoxicated or who deny that they have any problem, and various professionals. Political leaders are using the only problem-solving tactic known to them, which is to eliminate a very small portion of the problem through the "drug wars".
In the hospitals the costs of alcoholism is seen in the number of patient beds occupied by medical side effects of alcoholism. These side effects of alcoholism (whether it is acute or chronic) are an increased incidence of lung cancer, prostatic cancer, HIV (AIDS) syndromes, and other immunological and end organ consequences of ethanol toxicity.
A biological screen for alcoholism has been sought after for many years. In fact, the psychosocial and psychobiological understanding of the alcoholic patient has been a great mystery to man for at least 2,000 years. Today in modern society little is known about how a person may become an alcoholic, although, as mandated by a recent United States Supreme Court landmark case, it is strongly suggested that the behavior of an individual is the only key consideration as to whether a person will develop alcoholism; that is, it is not a disease state which is incorrect in many instances.
There have been numerous individuals and institutions who have devoted their lives to an attempt to understand this complex phenomenology. One approach which suggests that male children who are "role modeled" in a dysfunctional family are at higher risk to develop alcoholism than the average population if their fathers are alcoholic. This type of family dynamic leads one to understand that these children are felt in their own words to be abandoned, lost, neglected, appear to suffer from early deprivation of parental role modeling, and therefore are more likely to suffer from personality disorders that can become true psychopathological manifestations. It is this type of person who utilizes alcohol as a means to control the anger within towards the object relationships that so greatly disappoint them. This disappointment then leads to alcohol (an anesthetic drug) being used to soothe the pain of anger and punishment that they feel when they cannot achieve their high expected goals for the love, understanding, and nurturing that they did not receive as a child. Now as adults they are desperately looking for the parent that was not there for them. There is a strange reversal in this type of alcoholic personality which allows another close-loved human (the "enabler") to be used as a vehicle for the patient's own self destruction and eventual failure, the same treatment as they had received so many other times in their lives.
There is another type of alcoholic that cannot stop at "one drink" and who in the past has been referred to by several investigators as a "gamma drinker". These people may go long periods between the "binges", but when it starts they cannot stop drinking and/or substance abuse. This type of client will do anything to get alcohol/mixed chemical dependency pharmaceuticals. They even steal doctor's prescription pads or steal D.E.A. numbers to obtain their own medications in order to further the disease.
There are two types of substance dependence/abuse patients. As outlined by Diagnostic Statistical Manual Version III-R (DSM III-R), Psychoactive Substance Dependence requires at least three of the following criteria: 1. Substance often taken in larger amounts or over a longer period than the person intended; 2. Persistent desire or one or more unsuccessful efforts to cut down or control substance use; 3. A great deal of time spent in activities necessary to get the substance, taking the substance or recovering from its effect; 4. Frequent intoxication or withdrawal symptoms when expected to fulfill major role obligations at work, school, or home; 5. Important social, occupational, or recreational activities given up or reduced because of substance use; 6. Continued substance use despite knowledge of having a persistent or recurrent social, psychological, or physical problem that is caused or exacerbated by the use of the substance; 7. Marked tolerance: need for markedly increased amounts of the substance in order to achieve intoxication or desired effect; 8. Characteristic withdrawal syndromes; 9. Substance often taken to relieve or void withdrawal syndromes.
Psychoactive Substance Abuse is a separate category which is a residual category for noting "maladaptive patterns of psychoactive substance use." Diagnostic criteria for this as outlined in DSM III-R are: 1. A maladaptive pattern of substance use indicated by at least one of the following: a. Continued use despite knowledge of having a persistent or recurrent social, occupational, psychological, or physical problem that is caused or exacerbated by use of the psychoactive substance; b. Recurrent use in situations in which use is physically hazardous; 2. Some symptoms of the disturbance have persisted for at least one month, or have occurred repeatedly over a longer period of time; 3. Never met the criteria for Psychoactive Substance Dependence for this substance.
There appears to be a combination of the two alcoholic schemata which presents with a criteria as outlined in DSM III-R, referred to as Axis I diagnosis of alcohol abuse and/or dependency combined with an Axis II diagnosis of personality disorder (which includes primarily borderline personality, antisocial personality and narcissistic personality). These Axis II personality disorders have been thought of as temperament. This temperament, (some say we are born with these characteristics), is the phenotypic expression of one's own genetic inheritance related to male dominance. This temperament, of an individual's nature, has been thought to be the underlying cause of alcoholism derived from the male parent's temperament/alcoholism. Many behavioral theorists have tried with limited success for the past 40 years to treat alcoholism/chemical dependency in this manner.
Today, from a psychiatric and neuro-cell-biological aspect, physicians are beginning to see a glimpse of the importance of the psychodynamic aspects of the alcoholic environment and its profound effect on the children of the future/today, but it also has clinical measurable aspects as a disease entity, alcoholism. Alcoholism is a disease, and it can no longer be defined as just bad behavior. The definition of disease from Webster's New World Dictionary states: "1. any departure from health; illness in general. 2. a particular process in an organism, with a specific cause and characteristic symptoms". This disease state can and does affect the entire family dynamics, as well as affect the alcoholic individual in a particular manner with a specific cause and characteristic symptoms. What has been so confusing in the aspect of alcoholism is the effect on our whole society. To deal with it as a disease would mean that we would have to look at almost every aspect of our lives intermingled with our family dynamics, from all socioeconomic strata including health care providers and the legislators/political leaders.
The only known prior art associating lymphocytes with characterization of disease states are McAllister et al, Arch Gen Psychiatry 46 890-894 (1989) and Schleifer et al, Arch Gen Psychiatry 46 81-87 (1989). They do not relate to T-cell suppressor cells (CD8) and are concerned with patients with mental disorders. The techniques described by these references can be used in the present invention.